Clinical trial · Interventional
Combination of Methotrexate(MTX) and Actinomycin(ACTD) in the Low Risk Gestational Trophoblastic Neoplasma （GTN） Patients With Score of 5-6
Women's Hospital, Zhejiang University School of Medicine
NCT03885388CI-TRIAL-00037717unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this study, a prospective, multicenter randomized controlled study was conducted to compare the clinical efficacy and toxicity response of combination MTX+ACTD multi-course regimen in low-risk GTN patients with score 5-6 with standard MTX single-drug multi-course regimen.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Drug Toxicity | — | UNRESOLVED | — |
| Effects of Chemotherapy | — | UNRESOLVED | — |
| Gestational Trophoblastic Tumor | Gestational Trophoblastic Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MTX | Drug | Methotrexate | ALIAS |
| MTX+ACTD | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- control arm
- description
- single methotrexate multicourse treatment MTX:MTX 0.4mg/kg•d, intramuscular, every two weeks
- interventionNames
- Drug: MTX
- type
- EXPERIMENTAL
- label
- experimental arm
- description
- combination of methotrexate and actinomycin multicourse treatment, every two weeks MTX+ACTD:Act-d 0.6mg/m2 Day1,2 intravenous (IV) MTX 100mg/m2 IV Day1(after Act-d) MTX 200mg/m2 Ivgtt Day1(after MTX,500mlNS)
- interventionNames
- Drug: MTX+ACTD
Primary outcomes (1)
- measure
- primary complete remission
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Clinical diagnosis of gestational trophoblastic tumor; * Patients with prognosis score of 5 and 6 * Primary chemotherapy (preventive chemotherapy is not included); * Physical strength grade: Karnofsky score ≥ 60; * WBC ≥ 3.5× 109/L, ANC ≥ 1.5× 109/L, PT ≥ 80× 109/L, serum bilirubin ≤ 1.5 times of normal high limit, transaminase ≤ 1.5 times of normal high limit, BUN, Cr≤ normal; * Follow-up and good compliance; * Sign the informed consent form. Exclusion Criteria: * Pathological diagnosis is intermediate trophoblastic tumor, including PSTT and ETT； * There are serious or uncontrollable medical diseases, which are not suitable for chemotherapy; * Those who receive clinical trials of other drugs at the same time. * Those who receive Chinese medicine.
References
Publications (0)
Data not yet available
No reference posted for this study.